Clinical Outcomes and Cost-effectiveness Analysis of ShapeMatch Technology - Full Text View

Purpose

The currently held belief is that total knee replacement (TKR) requires the restoration of the overall limb alignment to coincide with the mechanical limb axis. To align the knee implants with this mechanical axis, rods are used to orient cutting guides with the mechanical axis as defined by the center of the femoral head and talus. Standard surgical technique typically involves femoral and tibial rods with cutting blocks to facilitate the intraoperative alignment of the initial femoral and tibia bone cuts. This approach is the method used for the traditional TriathlonÒ instrumentation. The Patient Specific Cutting Guides are designed to offer an alternative for alignment rods. ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment. The surgeon can then assess implant placement and adjust as necessary during pre-operative planning. Thus, Patient Specific Cutting Guides give the surgeon better control over the placement of the implants.

This study will be a prospective, randomized evaluation of ShapeMatch Technology for primary TKR in a consecutive series of patients who meet the eligibility criteria. The clinical study will be accompanied by a formal cost-effectiveness analysis of one-year outcomes.

One half of the cases enrolled will receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides designed to reproduce the natural kinematic alignment of the knee. The other half of the cases will receive the Triathlon® CR device in a procedure using traditional instrumentation, without navigation, designed to produce a neutral mechanical alignment. Subjects will be evaluated using validated measures within 3 months prior to surgery and at 6 weeks, 3 months, and 1 and 2 years postoperatively.

Primary Hypothesis:

The investigators expect that ShapeMatch Technology will be as cost-effective as usual care.

Secondary Hypotheses:

The investigators expect that ShapeMatch Technology will result in improved clinical outcomes relative to usual care at three months postoperatively.

The investigators expect that ShapeMatch Technology will result in similar clinical outcomes relative to usual care at two-years postoperatively.

Condition	Intervention	Phase
Total Knee Arthroplasty	Device: ShapeMatch Technology	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research
Official Title:	A Prospective, Randomized, Post-market, Multi-center Study and Cost-effectiveness Analysis of ShapeMatch Technology A Prospective, Randomized, Post-market, Multi-center Study and Cost-effectiveness Analysis of ShapeMatch Technology

Resource links provided by NLM:

MedlinePlus related topics: Knee Replacement

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:

Cost-effectiveness analysis (CEA) [ Time Frame: surgery to one year postoperatively ] [ Designated as safety issue: Yes ]
The CEA will examine the cost of health care resources and health outcomes from the surgical intervention to 1-year postoperatively. The costs will include all health care utilization during this time. Health care utilization, and associated costs, related to the patients' condition, the surgery and adverse events of the surgery will be the basis of a sensitivity analysis.

Quality adjusted life years (QALYs) is the preferred measure for CEA. QALYs will be calculated based on the EuroQol-5D (EQ-5D). An objective outcome measure may be used for additional analysis.

Secondary Outcome Measures:

Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: preoperative - 2 years postoperative ] [ Designated as safety issue: No ]
The KOOS is an instrument used to assess the patient's opinion about his or her knee and associated problems and has been validated for use in this population.
EuroQol-5D (EQ-5D) [ Time Frame: preoperative to 2-years postoperative ] [ Designated as safety issue: No ]
The EQ-5D is a generic health status questionnaire that will be used to measure overall health status and will be used in the CEA.
University of California at Los Angeles (UCLA) Activity Scale [ Time Frame: preoperative to 2-years postoperative ] [ Designated as safety issue: No ]
The UCLA activity score is a self-administered patient evaluation designed to reflect patient activity.
Forgotten Joint Score [ Time Frame: Imediate postoperative to 2 years postoperative ] [ Designated as safety issue: No ]
The Forgotten Joint Score is a recently developed tool that examines how aware the subject is of their TKR during activities of daily living.

Estimated Enrollment:	150
Study Start Date:	June 2012
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ShapeMatch Instrumentation	Device: ShapeMatch Technology ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment.
Active Comparator: Usual Instrumentation	Device: ShapeMatch Technology ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is a male or non-pregnant female age 18 to 80 years of age at the time of study device implantation.
Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
Patient is a candidate for a primary total knee replacement (TKR).
Patient is willing and able to comply with preoperative Magnetic Resonance Imaging (MRI) requirements, postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

Patient has a Body Mass Index (BMI) ≥ 40.
Patient has a varus or valgus deformity greater than 10 degrees or flexion contracture greater than 20o.
Patient has an active or suspected latent infection in or about the affected joint at time of study device implantation.
Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
Patient requires bilateral TKR, or has had a contralateral partial TKR or TKR.
Patient has any implanted device that would be incompatible with MRI procedures.
Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements(e.g. > 30 days).
Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
Patient has a known sensitivity to device materials.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01483066

Contacts

Contact: Lauren Beaupre, PT, PhD	780-407-3945	lauren.beaupre@albertahealthservices.ca
Contact: Gordon Arnett, MD, FRCS (C)	780-453-6999	garnett@edmontonortho.com

Locations

Canada, Alberta
Alberta Health Services - Edmonton zone	Recruiting
Edmonton, Alberta, Canada, TG6 2B7
Contact: Lauren Beaupre, PhD
Sub-Investigator: D Bill C Johnston, MD, FRCS (C)

Sponsors and Collaborators

Lauren Beaupre

Stryker Canada LP

Investigators

Principal Investigator:	Gordon Arnett, MD, FRCS (C)	Alberta Health Services
Study Director:	Lauren Beaupre, PT, PhD	University of Alberta

More Information

No publications provided

Responsible Party:	Lauren Beaupre, PT, PhD, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier:	NCT01483066 History of Changes
Other Study ID Numbers:	Pro00024283
Study First Received:	November 25, 2011
Last Updated:	August 23, 2012
Health Authority:	Canada: Ethics Review Committee

ClinicalTrials.gov processed this record on May 19, 2013